Medical Device Technical File

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What is Technical File?

The technical file for medical devices refers to all the documents that a medical device manufacturer has to submit to demonstrate that the product conforms to the applicable and current medical device regulations.

Technical files for medical devices shall include, e.g. a detailed description of the device and specification, reference to the previous and similar generation of the device, design information, pre-clinical testing information, clinical evaluation, and risk management of the medical device.

Technical file for medical devices shall be prepared by the medical device manufacturer and the information’s in the technical file or technical file for medical devices must be presented in a clear, organized, readily searchable, and unambiguous manner to demonstrate the safety and performance of the medical device in question.


Medical Device Technical File (MDR)

Want to prepare a medical device technical file as per the requirement of MDR 2017/745? If your answer is yes, you probably have lots of questions about the preparation of medical device technical files such as;

  • What shall be covered in the medical devices technical file?
  • Which Annex of -MDR 745/2017 shall be referred for the preparation of medical device technical file according to MDR?
  • Who will review and approve the medical device technical file?

We at Maven Profcon Services LLP, shall give you all the answers.

Medical device technical file shall be prepared as per the requirement of Annex II and Annex III of MDR 2017 / 745.

The technical file shall be submitted to the notified body or competent authority for review and approval for CE Certification. It should be made in the English language or the official language of an EU member state.

Under the MDR, the manufacturer shall safely store the technical documents for 10 years other than implantable device after the last device has been placed on the market, and in case of the implantable device, it should be safely stored for 15 years and non-EU manufacturer documents should be available with the Authorized Representative also.

Medical device manufacturers should be responsible for keeping the technical file up to date and in compliance with general safety and performance requirements Annex I, Annex II, and Annex III of MDR 2017/745.

Technical File content

Sr. No.SectionDescription
Section 1 General and Administrative Information.
1.1.0Table of Content
2.1.1Technical file approval team
3.1.2General information for the Technical file structure including purpose, scope
4.1.3Company Profile Name & Address of the Manufacture
6.1.4Authorized Representative name, address and contact details
7.1.5Notified Body Name, Number and Address
Section 2 Technical Documentation
8.2.1Device Description And Specification, Including Variants And Accessories
  • Device description and specification
  • Product name or trade name
  • General Description of Device
  • Intended Purpose
  • Indication of use
13. UDI-DI patient populations, including details of if applicable;

  • Medical Condition to be diagnostic, treatment, or monitoring
  • Patient selection criteria
  • Indication
  • Contraindications
  • Warning of operation including mode of action for considering the product as medical device Classification and Justification for the classification rule as per Annex VIII of Novel Features of Accessories of device Description of various configurations/variants description of key components for including software where appropriate required add photograph, drawing and Diagram of Raw Materials Specification like feature, dimension
25.2.2Reference of Previous and Similar Generations of the device
26.2.3Information Supplied by the Manufacturer Primary Label, Secondary label and Tertiary label

If you are selling device require specific county language then label should be available on that language for use (IFU)

If you are selling device require specific county language then IFU should be available on that language

29.2.4Design and Manufacturing Information design File process and their process validations Product Specification & Testing Environment Control the sites including supplier & subcontractors, where design activates are performed
35.2.5General Safety & Performance Requirements (GSPR) of Applicable Harmonized Standards, Common Specification (CS), Non-harmonized standards, applicable guidelines Safety & Performance Requirements (GSPR) of Conformity
39.2.6Benefit and Risk Analysis & Risk Management
40.2.7Product Verification and Validation
41.2.8Pre-clinical and Clinical Data and Clinical summary report of the device Safety and compatibility, Chemical & Microbiological Compatibility Verification and Validation or self-life & Safety Evaluation Report Marketing Activities

  • PMCF Plan & Report
  • PSUR Report
  • PMS Plan & Report
  • Tread Reports & Transportation information
53.2.9Additional Information is required in specific case: device incorporate a substance consider separately as medicine is manufactured by using tissue or cells of human or animal origin that are composed of substance or combination of substance or Endocrine-Disrupting Substance
58.2.10Detail of Device with measuring function
59.2.11Details of the device to be connected to other device to achieved its intended purpose
60.2.12Revision History
61.2.13Conclusion & Approval

Consultant for Technical Documentation

Our regulatory consultants in Maven who are experienced in various fields of Medical Device Regulations are well versed in taking care of technical documentation like clinical evaluation, Benefit-Risk Analysis, validations, design and development files, shelf life stability study, usability engineering file, safety and biological evaluation, and chemical characteristics evaluation.

Our regulatory consultants help you in identifying requirements as per EU MDR, identification of CE assessment route according to the class of the device, helps in clinical evaluation and also in post-marketing activities, risk analysis, and quality management implementation.

Maven as a developing medical device regulatory consultancy helps you in establishing your products in various countries with help of our experienced regulatory consultants. The below mentioned activities are taken care by us

  • Gap analysis of Medical Device Technical file as per the requirement of EU-MDR
  • Identification and classification of the medical device as per EU MDR
  • Help in selection of conformity route of assessment and Notified body
  • Preparation and Review of the technical documents as per EU MDR.
  • Help to maintain and update the technical file post certification.

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